Have over 28 years broad experience from QC to R&D, from pre-clinical to NDA/MAA and commercial product launch with more than 10 years as manager/supervisor and Director of Analytical Development & Quality Control (ADQC) in pharmaceutical/bio-pharmaceutical industry. Have extensive experience with CGMP, GLP, ICH, FDA and EMA guideline and industry practices. Have authored CMC sections of eCTD for NDA and MAA filing, response letters and for IND and IMPD submissions. Have managed more than 10 projects developed as analytical leader at CROs/CDMOs for drug substances and drug products include method transfer, method validation and stability program. Designed stability program includes bracketing and matrixing designs for stability testing. Have developed reversed phase, normal phase, ion-exchange, size-exclusion of HPLC methods and LC/MS for impurities profiles and potency assay, chiral separations and protein separations. Have experience for FDA and MAA on site pre-approve inspection (PAI) without any 483. Have supported drug product development from solid dosage, semi-solid, liquid dosage and injectable as well as cleaning validation. Have developed dissolution methods for QC release as well as in vivo-vitro correlation methods to support formulation development. Have 20 years’ experience of method transfer inside company and to external labs. Have built new analytical development group from 2 people to 8 direct reported people within 18 months. Have worked with IT for LIMS system development, and CMC samples tracking and reporting system.